Tag: Technology

HHS releases guidance on when HIPAA applies to mobile apps

Editor's Note The US Department of Health and Human Services (HHS) has released guidelines on how the Health Information Portability and Accountability Act (HIPPA) applies to health information a patient creates or manages through a health app and when app developers are required to comply with HIPPA rules. The new…

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By: Judy Mathias
February 17, 2016
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Texas Children’s wins ECRI Institute’s Health Devices Achievement Award

Editor's Note The ECRI Institute announced February 2 that Texas Children’s Hospital in Houston has won its 10th annual Health Devices Achievement Award. Texas Children’s winning submission, “Alarm Management Reboot,” describes the hospital’s efforts to improve patient safety by incorporating enterprise-wide alarm management practices to make alarms more meaningful and…

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By: Judy Mathias
February 2, 2016
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ECRI Institute launches ‘Rate This Model’ tool

Editor's Note ECRI Institute (Plymouth Meeting, Pennsylvania) on January 21 launched its new “Rate This Model” user review and rating tool for hospital equipment purchases. The tool enables OR managers to share their opinions and assign ratings on the performance of medical technologies. The new interactive feature looks and acts…

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By: Judy Mathias
January 21, 2016
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FDA: Draft cybersecurity recommendations for device manufacturers

Editor's Note The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices. The guidance builds on the FDA’s existing efforts to ensure the safety and effectiveness of medical devices at…

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By: Judy Mathias
January 20, 2016
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Simulation can be an affordable tool for improving care

How can OR managers better prepare staff to handle crisis situations? How can they encourage teamwork? Increasingly, OR leaders are turning to simulation to answer those questions.   OR leaders who think they can’t afford a high-fidelity manikin (one that talks and exhibits physiologic changes) and state-of-the-art simulation lab might…

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By: OR Manager
January 20, 2016
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Simulation lab a safe way to practice crisis management

Emergencies such as the one described above don’t happen frequently in the OR, but it is important to prepare for them, and simulation has emerged as an ideal educational tool. This scenario took place in a simulation lab, not a real OR, so the danger to the “patient” (manikin) consisted…

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By: OR Manager
January 20, 2016
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Dirty endoscopes top 2016 technology hazards list

OR Manager and ECRI Institute have joined in a collaboration to bring OR Manager readers periodic articles on topics such as medical technology management and procurement, risk management, and patient safety. ECRI Institute is an independent nonprofit that researches the best approaches to improving patient care.   Every year, hospitals…

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By: OR Manager
January 20, 2016
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FDA: Class I recall of Brainlab’s Cranial Image-Guided Surgery System

Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…

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By: Judy Mathias
January 19, 2016
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FDA issues draft guidance on UDI convenience kits

Editor's Note The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to…

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By: Judy Mathias
January 5, 2016
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ECRI Institute releases 2016 Top 10 Hospital C-suite Watch List

Editor's Note The ECRI Institute on January 4 released its annual Top 10 list of important technology related issues that hospital and health system leaders need to pay close attention to this year. The list includes: Medical device cybersecurity (eg, hacking into pacemakers) Miniature leadless pacemakers Changing landscape of robotic…

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By: Judy Mathias
January 4, 2016
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